Somatom Perspective 10495568Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869010335), received between Jul 28, 2021 and Sep 17, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K113287, K133590, K151765, K183548); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM PERSPECTIVE CT SCANNER. DURING A PROCEDURE, A PATIENT WAS CUT ON THE LEFT CALF BY THE EDGE OF THE TABLE. THE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT RESULTING IN STITCHES. NO OTHER INFORMATION WAS PROVIDED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Laceration(s)

  MAUDE report 23071139 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM PERSPECTIVE CT SYSTEM. AFTER PERFORMING THE DAILY QA, WHILE REMOVING THE PHANTOM, IT CAME APART AND HIT THE OPERATOR ON THE KNEE RESULTING IN A SMALL CUT APPROXIMATELY 2MM LONG.

  Patient problems: Abrasion

  MAUDE report 20437996 ↗
• InjuryOct 14, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM PERSPECTIVE CT SYSTEM. A PATIENT WAS ON THE TABLE AND IN THE SYSTEM THROUGH CHECK-UP OF THE SYSTEM. THE CUSTOMER REQUESTED ASSISTANCE WITH PROVISION OF A DOSE REPORT FOR THE CHECKUP / CALIBRATION ROUTINE GENERATED TO ASSIST WITH A POTENTIAL CLINICAL INCIDENT SURROUNDING UNNECESSARY RADIATION EXPOSURE TO A PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20437971 ↗
• MalfunctionJul 28, 2021Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED TO SIEMENS THAT THE TIP OF THE TECHNOLOGIST'S MIDDLE FINGER ON THE RIGHT HAND WAS "BURNT" (SHOCKED) WHILE SHE WAS TURNING ON THE LINE CONTROL BOX (LCB) VIA THE GREEN TOGGLE BUTTON AT THE S1 SWITCH. THE SYSTEM WAS DOWN AFTER THIS INCIDENT. SIEMENS FOLLOWED-UP WITH THE TECHNOLOGIST FOR ADDITIONAL INFORMATION AND TO CHECK HER HEALTH STATUS. THE TECHNOLOGIST STATED THAT SHE WAS FINE AND THAT THE "BURN" (SHOCK OR BURNING SENSATION) DID NOT HURT HER AND THAT SHE WASHED HER HANDS AFTER THE INCIDENT. SHE AND THE OTHER FACILITY STAFF DID NOT SEE ANY SIGNS OF INJURY TO HER FINGER AFTER SHE WASHED HER HANDS. SINCE THERE WAS NO ACTUAL BURN OR OTHER INJURY, NO MEDICAL TREATMENT WAS REQUIRED IN THIS CASE. THE TECHNOLOGIST STATED THAT IT APPEARED THE ELECTRICAL CURRENT TRAVELED FROM THE S1 SWITCH THROUGH THE MIDDLE FINGER OF RIGHT HAND TO THE OUTER COVER TO THE GROUND. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Electric Shock

  MAUDE report 12239043 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113287, K133590, K151765, K183548. One submission often covers many models, so check the product and lot details in each record.

• Z-1448-2018 · Feb 15, 2018 · Terminated
  SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
• Z-2474-2018 · Feb 1, 2018 · Terminated
  SOMATOM Perspective (Model 10495568)
• Z-2475-2018 · Feb 1, 2018 · Terminated
  SOMATOM Perspective 16 (Model 10891666)
• Z-0921-2017 · Nov 22, 2016 · Terminated
  SOMATOM Perspective, Computed tomography x-ray system
• Z-1646-2015 · Apr 20, 2015 · Terminated
  SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the